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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06073821




Registration number
Help: Registration number
NCT06073821
Ethics application status
Help: Ethics application status
Date submitted
Help: Date submitted
3/10/2023
Date registered
Help: Date registered
10/10/2023
Date last updated
Help: Date last updated
14/10/2026

Titles & IDs
Public title
Study of Sonrotoclax (BGB-11417) Plus Zanubrutinib (BGB-3111) Compared With Venetoclax Plus Obinutuzumab in Participants With Chronic Lymphocytic Leukemia (CLL)
Scientific title
A Phase 3, Open-Label, Randomized Study of Sonrotoclax (BGB-11417) Plus Zanubrutinib (BGB-3111) Compared With Venetoclax Plus Obinutuzumab in Patients With Previously Untreated Chronic Lymphocytic Leukemia
Additional trial identifiers [1] 0 0
CTR20241195
Additional trial identifiers [2] 0 0
BGB-11417-301
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
CLL 0 0
Condition category
Condition code
Cancer 0 0 0 0
Leukaemia - Chronic leukaemia

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
Treatment: Drugs - Sonrotoclax
Treatment: Drugs - Zanubrutinib
Treatment: Drugs - Venetoclax
Treatment: Drugs - Obinutuzumab

Experimental: Sonrotoclax Plus Zanubrutinib - Participants will receive from start of Cycle 1 a standard dose of zanubrutinib once or twice daily orally and in combination with sonrotoclax starting from Cycle 4 onwards at increasing doses until target dose is reached and continuing until end of Cycle 15 (each cycle is 28 days)

Active comparator: Venetoclax Plus Obinutuzumab - Participants will receive obinutuzumab 100mg intravenously on Day 1 Cycle 1, followed by 900 mg on Day 2 Cycle 1 (or alternatively receive 1000 mg intravenously on Day 1), followed by 1000 mg on Days 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2 through 6 (each cycle is 28 days) in combination with venetoclax at increasing doses until target dose is reached from Day 22 Cycle 1 until end of Cycle 12 (each cycles is 28 days)


Treatment: Drugs: Sonrotoclax
Administered orally

Treatment: Drugs: Zanubrutinib
Administered orally

Treatment: Drugs: Venetoclax
Administered orally

Treatment: Drugs: Obinutuzumab
Administered intravenously
Intervention code [1] 0 0
Treatment: Drugs
Description of the comparator or control
Control group

Outcomes
Primary outcome [1] 0 0
Cohort 1: Progression Free Survival (PFS)
Timepoint [1] 0 0
Up to approximately 9 years
Primary outcome [2] 0 0
Cohort 1: Rate of Undetectable Measurable Residual Disease
Timepoint [2] 0 0
Up to one and a half years
Secondary outcome [1] 0 0
Cohort 1: Overall Survival (OS)
Timepoint [1] 0 0
Up to approximately 9 years
Secondary outcome [2] 0 0
Cohort 1: Complete Response Rate (CRR ) by IRC
Timepoint [2] 0 0
Up to approximately 9 years
Secondary outcome [3] 0 0
Cohort 1: PFS by Investigator Assessment
Timepoint [3] 0 0
Up to approximately 9 years
Secondary outcome [4] 0 0
Cohort 1: CRR by Investigator Assessment
Timepoint [4] 0 0
Up to approximately 9 years
Secondary outcome [5] 0 0
Cohort 1: Rate of Undetectable Measurable Residual Disease
Timepoint [5] 0 0
Up to approximately 9 years
Secondary outcome [6] 0 0
Cohort 1: Overall Response Rate (ORR) by IRC and Investigator Assessment
Timepoint [6] 0 0
Up to approximately 9 years
Secondary outcome [7] 0 0
Cohort 1: Duration of Response (DOR) by IRC and Investigator Assessment
Timepoint [7] 0 0
Up to approximately 9 years
Secondary outcome [8] 0 0
Pooled Cohorts: PFS by IRC and Investigator Assessment
Timepoint [8] 0 0
Up to approximately 9 years
Secondary outcome [9] 0 0
Pooled Cohorts: ORR by IRC and Investigator Assessment
Timepoint [9] 0 0
Up to approximately 9 years
Secondary outcome [10] 0 0
Pooled Cohorts: DOR by IRC and Investigator Assessment
Timepoint [10] 0 0
Up to approximately 9 years
Secondary outcome [11] 0 0
Pooled Cohorts: Rate of Undetectable Measurable Residual Disease
Timepoint [11] 0 0
Up to approximately 9 years
Secondary outcome [12] 0 0
Pooled Cohorts: CRR by IRC and Investigator Assessment
Timepoint [12] 0 0
Up to approximately 9 years
Secondary outcome [13] 0 0
Cohort 1 and Pooled Cohorts: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Timepoint [13] 0 0
Up to one and a half years for Sonrotoclax Plus Zanubrutinib group and 13 months for Venetoclax Plus Obinutuzumab group]
Secondary outcome [14] 0 0
Cohort 1 and Pooled Cohorts: Change from baseline in European Organization for Research and Treatment of Cancer Quality of Life Cancer Questionnaire -Core 30 (EORTC QLQ-C30) Global Health Status/QoL (GHS) and Physical Functioning Scales
Timepoint [14] 0 0
Every three cycles during the treatment period
Secondary outcome [15] 0 0
Cohort 1 and Pooled Cohorts: Change from baseline in EORTC Quality of Life Questionnaire - Chronic Lymphocytic Leukemia Module 17 Items (QLQ-CLL17) Symptom Burden and Physical Condition Scales
Timepoint [15] 0 0
Every three cycles during the treatment period
Secondary outcome [16] 0 0
Cohort 1 and Pooled Cohorts: Change from baseline in European Quality of Life 5-Dimensions 5-Levels Health Questionnaire (EQ-5D-5L) Visual Analogue Scale (VAS).
Timepoint [16] 0 0
Every three cycles during the treatment period

Eligibility
Key inclusion criteria
* Treatment-naïve (TN) adults with confirmed diagnosis of CLL which requires treatment
* Eastern Cooperative Oncology Group (ECOG) score 0, 1, or 2
* Measurable disease by Computer Tomography/Magnetic Resonance Imaging
* Adequate liver function as indicated by aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 2.5 x the institutional upper limits of normal (ULNs) value; serum total bilirubin < 3.0 x ULN
* Adequate renal function as defined as creatinine clearance = 50 milliliters per minute
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
* Previous systemic treatment for CLL
* Known prolymphocytic leukemia or history of, or currently suspected, Richter's transformation
* Known central nervous system involvement
* History of confirmed progressive multifocal leukoencephalopathy (PML)
* Uncontrolled hypertension

Note: Other protocol defined criteria may apply

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
11/11/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2032
Actual
Sample size
Target
652
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Concord Repatriation General Hospital - Concord
Recruitment hospital [2] 0 0
Genesiscare North Shore - St Leonards
Recruitment hospital [3] 0 0
Pindara Private Hospital - Benowa
Recruitment hospital [4] 0 0
Sunshine Coast Hospital and Health Service - Birtinya
Recruitment hospital [5] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [6] 0 0
Flinders Medical Centre - Bedford PK
Recruitment hospital [7] 0 0
Monash Health - Clayton
Recruitment hospital [8] 0 0
St Vincents Hospital Melbourne - Fitzroy
Recruitment hospital [9] 0 0
Austin Health - Heidelberg
Recruitment hospital [10] 0 0
Cabrini Hospital Malvern - Malvern
Recruitment hospital [11] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [12] 0 0
Hollywood Private Hospital - Nedlands
Recruitment postcode(s) [1] 0 0
NSW 2139 - Concord
Recruitment postcode(s) [2] 0 0
NSW 2065 - St Leonards
Recruitment postcode(s) [3] 0 0
QLD 4217 - Benowa
Recruitment postcode(s) [4] 0 0
QLD 4575 - Birtinya
Recruitment postcode(s) [5] 0 0
QLD 4102 - Woolloongabba
Recruitment postcode(s) [6] 0 0
SA 5042 - Bedford PK
Recruitment postcode(s) [7] 0 0
VIC 3168 - Clayton
Recruitment postcode(s) [8] 0 0
VIC 3065 - Fitzroy
Recruitment postcode(s) [9] 0 0
VIC 3084 - Heidelberg
Recruitment postcode(s) [10] 0 0
VIC 3144 - Malvern
Recruitment postcode(s) [11] 0 0
VIC 3004 - Melbourne
Recruitment postcode(s) [12] 0 0
WA 6009 - Nedlands
Recruitment outside Australia
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United States of America
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Alaska
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California
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District of Columbia
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Florida
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Innsbruck
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Salzburg
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Austria
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Vienna
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Botucatu
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Brazil
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Curitiba
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Brazil
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Porto Alegre
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Brazil
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Ribeirão Preto
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Brazil
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Anhui
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Beijing Municipality
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China
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Chongqing Municipality
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Liaoning
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Chiba
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Ehime
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Hokkaido
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Hyogo
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Kagoshima-ken
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Kanagawa
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Miyagi
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Osaka
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Tokyo
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Kumamoto
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Tauranga
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Wellington
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Lodz
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Lublin
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San Juan
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Gyeonggi-do
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South Korea
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Seoul Teugbyeolsi
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Spain
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Burgos
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Spain
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L'Hospitalet de Llobregat
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Spain
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Las Palmas de Gran Canaria
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Spain
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Madrid
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Spain
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Santa Cruz de Tenerife
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Sweden
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Stockholm
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Turkey (Türkiye)
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Ankara
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Kayseri
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Turkey (Türkiye)
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Kocaeli
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United Kingdom
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Bournemouth
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Canterbury
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Headington
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Liverpool
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London
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Norwich
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Southampton
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United Kingdom
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Sutton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
BeOne Medicines
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Study Director
Address 0 0
Country 0 0
Phone 0 0
1-877-828-5568
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
BeOne shares data on completed studies responsibly and provides qualified scientific and medical researchers access to data and supporting documentation for clinical trials in dossiers for medicines and indications after submission and approval in the United States, China, and Europe. Clinical trials supporting subsequent local approvals, new indications, or combination products are eligible for sharing once corresponding regulatory approvals are achieved.

BeOne shares data only when permitted by applicable data privacy and security laws and regulations, when it is feasible to do so without compromising the privacy of study participants, and other considerations.

Qualified researchers with appropriate competencies who are engaged in novel scientific research may submit a request for participant-level data with a research proposal for BeOne review. Research teams must include a biostatistician and sign a Data Sharing Agreement prior to receiving access to clinical trial data.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
See plan description
Available to whom?
See plan description
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://beonemedicines.com/science/clinical-trials/


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT06073821